Federal Register / Vol. 72, No.
57 / Monday, March 26, 2007 / Notices 14123
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: September 19,
1997. The applicant claims September
20, 1997, as the date the investigational
new drug application (IND) became
effective. However, FDA records
indicate that the IND effective date was
September 19, 1997, which was 30 days
after FDA receipt of the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: September 3, 2002.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
EMTRIVA (NDA 21–500) was initially
submitted on September 3, 2002.
3. The date the application was
approved: July 2, 2003. FDA has verified
the applicant’s claim that NDA 21–500
was approved on July 2, 2003.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 642 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by May 25, 2007.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 24, 2007. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
cprice-sewell on PROD1PC66 with NOTICES
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VerDate Aug<31>2005 15:30 Mar 23, 2007 Jkt 211001
Dated: February 26, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–5446 Filed 3–23–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 24, 2007, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Ronald P. Jean,
Center for Devices and Radiological
Health (HFZ–410), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850, 240–276–3676, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512521. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will discuss,
make recommendations and vote on a
premarket approval application (PMA)
for the Scandinavian Total Ankle
Replacement System, sponsored by Link
America, Inc. This system is intended
for use as a noncemented implant to
replace a painful arthritic and/or
severely deformed ankle due to
rheumatoid arthritis, primary arthrosis,
or posttraumatic arthrosis.
FDA intends to make background
material available to the public no later
than 1 business day before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\26MRN1.SGM
will be posted on FDA’s Web site after
the meeting. Background material is
available athttp://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 10, 2007. Oral
presentations from the public will be
scheduled for 30 minutes at the
beginning of the committee
deliberations and for 30 minutes near
the end of the deliberations. Those
desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 2,
2007. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 3, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, at 301–827–7292, at least 7 days
in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 20, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–5469 Filed 3–23–07; 8:45 am]
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